Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

Prior treatment

• Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
• Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
• Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU)
• Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent

Other illness

• Active cancer in any other location
• BCG first instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc

Other

• No muscle layer in pathological examination piece's
• Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• Patients with difficulties to perform the follow-up visits established in the protocol.
• Non-urothelial tumor
• Administration of BCG in the last year before signing the informed consent.

• Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection
• Age between 18 and 85 years at the time of signing the informed consent.
• Urothelial tumor
• High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
• Patient with risk of recurrence or progression greater than or equal to 7 points, according to CUETO tables